Flushable drainage device and method of use

ABSTRACT

A flushable valve which has unidirectional flushing can be used to flush a lumen of a stem, catheter and/or tubing. By flushing the stent, catheter and/or tubing, particulates or residue that can block or impede the flow of fluid out of the stent, catheter and/or tubing can be overcome thereby facilitating continued drainage. An automatic flushable valve eliminates manual manipulation of the device. In an embodiment of the invention, a back pressure sensor can be used to detect when the flow through the stent, catheter and/or tubing has become impeded and activates a flushing cycle. In an embodiment of the invention, a leak detector can be used to detect when an operation has caused the flush device to leak. In various embodiments of the invention, the back pressure sensor and the leak detector can be used to detect that the flush device is operating under normal conditions.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/905,904, filed May 30, 2013, now U.S. Pat. No. 9,814,866, whichclaims priority to U.S. Provisional Application No. 61/653,960 entitledFlushable Drainage Device and Method of Use, filed May 31, 2012, all ofwhich are expressly incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to valves used in flushing procedures forcatheters or tubes.

BACKGROUND OF THE INVENTION

In the medical field, tubes and catheters are used in a wide variety ofapplications including drainage procedures or applications. In thesetypes of applications, the tubes or catheters are of the type whichcarry various bodily fluids, including but not limited to, abscessfluids, urinary fluids, and biliary fluids. One purpose of these tubesor catheters is to decompress, relieve, or drain a specific collectionof fluid. The expressed fluid is amassed into a collection bag forevaluation or evacuation.

It is important that the interior passageway or lumen in these devicesremain unobstructed from particulates and/or residues which can collector build-up on the surface of the lumen in the catheter or tube. Thebuild-up of particulates and/or residues on the interior surface of thelumen in the tube or catheter can lead to uneven, reduced, or obstructedflow. Obstructed, limited, or even uneven fluid flow can extend therecovery time of a patient, resulting in the potential for furthercomplications or infections. For example, an infection can causecomplications in the patient's treatment leading to sickness or evendeath. These problems are particularly accentuated with those cathetersor tubes which are kept in place for longer periods of time.

As a result, the tubes or catheters must be periodically flushed toensure that there is not a build-up of particulates or residue in thelumen that will block or impede the flow of fluid out of the patient.Flushing these medical devices usually involves attaching a source ofcleansing fluid, such as a saline solution, and directing the cleansingfluid under low pressure through the tube or catheter to remove anybuild-up occurring in the lumen. The flushing fluid can then be allowedto flow out the tube or catheter into the drainage bag.

When it is time to flush the tube or catheter, the drainage bag can bedisconnected and the source of cleansing fluid, usually a syringe, canbe attached to the tube or catheter that is fluidly connected to thepatient. Once the cleansing fluid has been directed into the tube orcatheter, the syringe or other source of cleansing fluid, can bedisconnected and the drainage bag can be reattached. This procedure isparticularly unsatisfactory because of the time required to unscrew thedrainage bag, and attach the syringe, and then to unscrew the syringeand reattach the drainage bag. In addition, after the cleansing fluidhas been directed into the tube or catheter that is attached to thepatient, there is a risk of fluid leaking during the un-attaching andreattaching process which can cause an unsanitary condition andpotentially expose medical personnel and the patient to contamination.Further, if any fluid is accidentally discharged during this process,the medical personnel must take the time to sanitize the patient, thebedding, and themselves.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, the flushing device is anintuitive unidirectional valve for regulating flow through two ports.

In an embodiment of the present invention, the flushing device allowsscheduled periodic automatic flush. In an embodiment of the presentinvention, the flushing device undertakes a scheduled flushing of thestent, catheter and/or tubing to remove particulates that can lead toclogging of the stent, catheter and/or tubing. In various embodiments ofthe present invention, the flushing device undertakes the scheduledflushing of the stent, catheter and/or tubing at regular intervals. Inan embodiment of the present invention, the flushing device undertakesthe scheduled flushing of a filter at regular intervals. In anembodiment of the present invention, the flushing device alerts thephysician and/or user when flushing fails to unclog the stent, catheterand/or tubing. In an embodiment of the present invention, the flushingdevice alerts the physician and/or user when flushing fails to unclogthe filter. In an embodiment of the present invention, the flush devicealerts personnel when the drainage receptacle requires maintenance. Inan embodiment of the present invention, the flush device valve alertspersonnel when there is a leak in the flush device valve system.

BRIEF DESCRIPTION OF THE DRAWINGS

This invention is described with respect to specific embodimentsthereof. Additional features can be appreciated from the Figures inwhich:

FIG. 1A shows a prior art three way stop-cock valve;

FIGS. 1B(i)-(iv) show a prior art three way stop-cock valve with thestem orientated in four (4) different directions to direct the flow;

FIG. 2 shows a perspective view of a flush device according to anembodiment of the invention;

FIG. 3A shows a perspective view of a flush device according to anembodiment of the invention;

FIG. 3B shows a side view of a flush device in the ‘drain’ configurationand the direction of movement of the flange or valve plate from the‘flush’ configuration according to an embodiment of the invention;

FIG. 3C shows an overhead view of a flush device according to anembodiment of the invention;

FIG. 3D shows a side view of a flush device in the ‘drain’ configurationaccording to an embodiment of the invention;

FIG. 3E shows a side view of a flush device in the ‘flush’ configurationaccording to an embodiment of the invention;

FIG. 4A shows a section schematic of a flush device system in the‘drain’ configuration according to an embodiment of the invention;

FIG. 4B shows a section schematic of a flush device system in the‘flush’ configuration according to an embodiment of the invention;

FIG. 4C shows the movement of the flange or valve plate relative to asection schematic of a flush device system according to an embodiment ofthe invention; and

FIG. 5 shows a schematic diagram of a flush device connecting to a stentor catheter connected to an internal organ according to an embodiment ofthe invention.

DETAILED DESCRIPTION OF THE INVENTION Definitions

The transitional term “comprising” is synonymous with “including,”“containing,” or “characterized by,” is inclusive or open-ended and doesnot exclude additional, unrecited elements or method steps.

The transitional phrase “consisting of” excludes any element, step, oringredient not specified in the claim, but does not exclude additionalcomponents or steps that are unrelated to the invention such asimpurities ordinarily associated with a composition.

The transitional phrase “consisting essentially of” limits the scope ofa claim to the specified materials or steps and those that do notmaterially affect the basic and novel characteristic(s) of the claimedinvention.

As used herein, the term “check valve” refers to a device that has atleast two openings in the body of the device, one for fluid to enter andthe other for fluid to leave, and a mechanism to control the flow.

A ball check valve has a movable spherical ball part to block the flow.In some ball check valves, the ball is spring-loaded to help keep itshut. For those designs without a spring, reverse flow is required tomove the ball toward the seat and create a seal. The interior surface ofthe main seats of ball check valves are more or less conically-taperedto guide the ball into the seat and form a positive seal when stoppingreverse flow. The balls can be made of metal or other materialsincluding artificial ruby. High pressure liquid chromatography pumps canuse small drainage and inlet ball check valves with either balls and/orseats made of artificial ruby, for both hardness and chemicalresistance.

A flange check valve can use a disc as a flange, rather than a ball, toblock flow in a specific direction and allow flow in another direction.The flange can be circular, square, triangular or poly-sided (includinga pentagon, a hexagon, a heptagon, an octagon, a nonagon, a decagon, ahendecagon, a dodecagon, a tridecagon, a tetradecagon or a pentadecagon)or some other shape. The flange can also be a combination of one or moreof these shapes. Thus the flange can be mostly circular in shape butmissing the area corresponding with an arc of the circle. The flange canincorporate a hinged section to retain the flange in the body of thevalve while allowing the hinged portion to swing and change thedirection of flow. Thus the mostly circular flange missing the arc areacan be hinged along the line that intersects the extremities of the arc.A spring can be used to return the hinged section of the flange to aspecific position. For example a spring can realign the hinged sectionof the flange on cessation of a positive pressure associated with flowof the fluid.

A mushroom check valve can use a hole with a tapered plug, such as apoppet energized by a spring.

A diaphragm check valve can use a flexing rubber diaphragm positioned tocreate a normally-closed valve. Pressure on the upstream side must begreater than the pressure on the downstream side by a certain amount,known as the pressure differential, for the diaphragm to open allowingflow. Once positive pressure stops, the diaphragm automatically flexesback to its original closed position.

A swing check valve or tilting disc check valve is a check valve inwhich the disc, the movable part to block the flow, swings on a hinge ortrunnion, either onto the seat to block reverse flow or off the seat toallow forward flow. The seat opening cross-section may be perpendicularto the centerline between the two ports or at an angle.

A lift-check valve can have a disc which can be lifted up off its seatby higher pressure of drainage or upstream fluid to allow flow to theinlet or downstream side. A guide keeps motion of the disc on a verticalline, so the valve can later reseat properly. When the pressure is nolonger higher, gravity or higher downstream pressure will cause the discto lower onto its seat, shutting the valve to stop reverse flow.

A duckbill valve is a check valve in which flow proceeds through a softtube that protrudes into the downstream side. Back-pressure collapsesthis tube, cutting off flow.

An electrical valve uses an electrical signal to open or close a valve.The electrical signal can drive a disc to open flow through a port.

A solenoid valve uses an electrical current through a solenoid to openor close a valve. When no electricity is applied, the valve returns toan inert position which can be used to secure the valve in a closedposition in the event of an electrical failure.

A two way valve can use a check valve to direct the flow as ‘on’ or‘off’. A three way valve can use a check valve to direct inflow to oneof two inlets.

A stop-check valve is a check valve with override control to stop flowregardless of flow direction or pressure. In addition to closing inresponse to backflow or insufficient positive pressure, it can also bedeliberately shut by an external mechanism, thereby preventing any flowregardless of positive pressure.

Fluid level detection and fluid detection can be accomplished using athermal resistance probe and monolithic bipolar integrated circuits suchas the LM1042 Fluid Level Detector and LM1830 Fluid Detector fromNational Semiconductor. The fluid detector can be adjusted for theimpedance of the flushing fluid.

An alarm can be a light emitting diode, a loud speaker, or a low currentrelay. An alarm can trigger an SMS or other message to a computer, or acell phone or ring a pager or a cell phone.

In general, the above valves can be activated to switch from one flowconfiguration to a second flow configuration by application of signaleither, mechanical (pressure, gears or contact) or electrical tostimulate a change in the physical configuration of the valve. Multiplecheck valves can be connected in series. For example, a double ballcheck valve in which there are two ball/seat combinations sequentiallyin the same body can ensure positive leak-tight shutoff when blockingreverse flow.

It is well known that fluids need to be removed from patients. Fluidremoval systems typically include one or more flexible plastic tubesconnecting an organ or tissue to be drained and an in-line filterconnected to the one or more containers. In many instances, it isdesirable to switch from one fluid container to another during patientadministration either for purposes of changing the fluid beingcollected, or to flush the fluid delivery set-up to prevent blockage ofthe fluid line from occurring during use. A device commonly referred toas a three-way stopcock, can be used to flush a stent or a catheter. Thethree-way stopcock valve is a staple in the hospital setting for avariety of applications including the plumbing of W tubing and catheterflushing. The device is low cost and can be reliable when used properly.The three-way stopcock valve can make it easier for medical personnel toflush a stent or a catheter and to reduce the risk of contamination andspillage. The three-way stopcock can be attached to the tube or catheterthat is fluidly connected to the patient and connects the tube orcatheter to the drainage bag.

The three way stop-cock valve 100 allows the passage of a bodily fluidfrom an inlet 180 to a drainage 170 connected to a container (not shown)and the introduction of a solution through a third port 160 to rinse thefilter (not shown) (see FIG. 1A). Such valves normally employ arotatable 112 stem 110 which allows the operator thereof to temporarilychange the fluid flow from the organ communicating with the container byrotation of the stem relative to the valve (see FIG. 1B). The drainageflow 181 can be directed to the inlet 171 (see FIG. 1B(i)) or splitbetween the inlet 171 and the third port 161 (see FIG. 1B(ii)).Similarly by rotating the stop-cock stem 110, the drainage 180 can beisolated and the inlet flushed through the third port 160 (see FIG.1B(iii)). Alternatively, the stop-cock stem 110 can be rotated so thatthe inlet 170 can be isolated and the inlet 180 flushed through thethird port 160 (see FIG. 1B(iv)). In this manner, a saline solution canthen be directed through the three way valve into the drainage line torinse the filter (see FIG. 1B(iv)). After removal of the saline syringeand sterilization of the three way valve, a blocking cap can be insertedon that port and by rotation of the stem relative to the valve canreturn the three way valve such that the fluid flow from the organ againcommunicates with the container (see FIG. 1B(i)).

Typically the three-way stopcock 100 has a valve that can be manuallymoved by the medical personnel who is going to perform the flushingprocedure to direct the flow of fluid either into a drainage bag or toan outside port for periodic catheter maintenance or flushing. Thisallows the fluid source, such as a syringe, to be attached to the thirdport when it is time to flush the tube or catheter. Once the syringe isattached, the three-way stopcock can be manually moved to stop the fluidflowing to the container or drainage bag (see FIG. 1B(iv)). This allowsthe cleansing fluid to be directed into the tube or catheter. Once allthe cleaning fluid is in the tube or catheter, the three-way stopcockcan be manually moved back to its original position allowing fluid toflow into the drainage bag (see FIG. 1B(i)).

While the three-way stopcock 100 is an improvement over the manualflushing procedure, there have been various problems with the three-waystopcock 100. Stopcocks have failed from usage or have had certainlimitations to their use. One of the problems with using a three-waystopcock is that the nurse or attendant must manually adjust thethree-way stopcock to cease the flow of fluid in the drainage catheterand open the flushing access port to enable the flushing fluid to bedirected into the lumen of the tube or catheter (see FIG. 1B(i) and FIG.1B(iv)). One of the primary difficulties with the three way stop cockvalve 100 is that it is not always apparent to the operator whichposition relates the fluid flow communication from the patient to thecontainer. This is particularly true when the fluid being drained isslow moving. Two of the positions shown in FIG. 1B have no relevance(see FIG. 1B(ii) and FIG. 1B(iii)). Another common difficulty withstop-cock valves of this type is that of ensuring that the stop-cockvalve remains sterile after it is placed in use, i.e., the completesterilization of the fluid flow channels within the rotating stemthereof. Once the cleansing fluid has been directed into the tube or thecatheter, the three-way stopcock must again be manually adjusted toredirect the fluid flow into the drainage bag (see FIG. 1B). These extrasteps are time consuming and cumbersome requiring the attendant's and/ornurse's concentration to detail and valuable time, which are often inshort supply. There is also a possibility that the manual adjustmentsthat are required can confuse the person carrying out the flushingprocedure which then has the potential to misdirect the fluid flow outof the patient (see FIG. 1B(ii) and FIG. 1B(iii)). In addition, if forsome reason the person fails to return the three-way stopcock to theoriginal position which allows the fluid to flow to the drainage bag,fluid will flow out the flushing access port (see FIG. 1B(ii)) andcontaminate the patient and the surrounding facilities and generallycreate a potentially dangerous situation. This can result in loss offluids that are needed to monitor the health of the patient as well ascreating an unsanitary condition. If the attendant fails to return thethree-way stopcock from the flushing position, no drainage of thepatient's fluids will ensue which can have a debilitating and even lifethreatening consequence for the patient (see FIG. 1B(iii)). A furtherproblem with existing three-way stopcocks 100 is that the diameter ofthe passageway formed through the three-way stopcock is typicallysmaller than the diameter of the lumen in the tube or catheter to whichthe three-way stopcock 100 is attached. As a result, the passageway ofthe three-way stopcock 100 through the stem 110 impedes the fluid flowby creating a bottleneck effect as the fluid tries to flow through thethree-way stopcock 100. The present invention addresses these problemsand issues of the prior art as discussed below in detail.

In various embodiments of the present invention, the flush device 210can be seen in FIGS. 2-5. In FIGS. 2 and 3, the flush device 210comprises a flange or valve plate 220, a channel 250, a flushing accesschannel 262, a flushing access port 260, an inlet port 280 and inletconnector 282, and a drainage port 270 and drainage connector 272 eachwith threaded 274 and 284 portions respectively. FIG. 2 shows a taperedflushing access port 262 suitable for a Luer lock syringe. The flange orvalve plate 220 also comprises a hinge 230 (see FIGS. 3B-3E). The flushdevice 210 also comprises an in-line valve seat 240 (see FIG. 3B). Theflange or valve plate 220 can be secured to the hinge 230 and can rotatebetween a first position (see FIG. 3D) and a second position (see FIG.3E). In the first position, the flange or valve plate 220 can be locatedsuch that it does not interfere with the flow of fluid and/or materialsas they move through the channel 250 from the drainage port 270 to theinlet port 280. In an embodiment, the flange or valve plate 220 can behoused in the flushing access channel 262 when in the first position. Inan embodiment of the present invention, the flange or valve plate 220can be mostly circular with an area corresponding to the areaencompassed by an arc of the circle and the line connecting theextremities of the arc missing from the area of a circle or embeddedinto the housing 219 of the flush device 210 (See FIG. 3B). In anembodiment of the present invention, the mostly circular flange or valveplate 220 can include a hinge 230 along the straight side (correspondingto the line connecting the extremities of the arc). In an embodiment ofthe present invention, the mostly circular flange or valve plate 220 caninclude a spring (not shown) to return the mostly circular portion ofthe flange or valve plate 220 to a set return position (see FIG. 4C). Inan embodiment of the present invention, the absence of positive pressureat the flange or valve plate 220 would move back to the return position.In an embodiment of the present invention, attaching a pump or syringe405 to the flushing port 260 moves a lever (not shown) which displacesthe flange or valve plate 220 connecting the flushing port 260 and theinlet port 280. Removal of the pump or syringe 405 connection from theflushing port 260 moves the flange or valve plate 220 back to the returnposition. In an embodiment of the present invention, the center of theflange or valve plate 220 can be off center to the center of the channel250. In an embodiment of the invention, despite the offset of the flangeor valve plate 220 relative to the center of the channel 250, the flangeor valve plate 220 can seal on the valve seat 240.

In an embodiment of the present invention shown in FIG. 3A-FIG. 3E, FIG.4A-FIG. 4B and FIG. 5A-FIG. 5B, the automatic flush device 210 has aflange or valve plate 220 that moves in response to the fluid pressureapplied by the action of a flush fluid being introduced into the flushdevice 210 via the flushing access port 260. The flange or valve plate220 moves from a first position (see FIG. 3D; FIG. 4A; FIG. 5A) to asecond position (see FIG. 3E; FIG. 4B; FIG. 5B), wherein the flange orvalve plate 220 abuts the in-line valve seat 240. When moving from thefirst position to the second position, the flange or valve plate 220rotates about a hinge 230. In the second position, the valve plate 220substantially prevents flush fluid from flowing into the drainage port270 and directs the flush fluid into the inlet port 280. Thus, the flushfluid, and pressure thereof, can be directed out of the inlet port 280entrance passage way and towards any occlusion in the attached pathway.As shown in FIG. 4A-FIG. 4C, a syringe head 405 can be screwed into thethread 409 of the flushing access port 262. The flange or valve plate220 can seal on the valve seat 240. Similarly, the tubing connecting thecatheter or stent via the inlet port 280 to the flush device 210 and thetubing connecting the flush device 210 to the drain bag can be connectedto the flush device 210 by threading to the thread 274 of a screw fitconnector.

In an embodiment of the present invention shown in FIG. 2 and FIG. 3Athe flushing access channel 262 comprises a flushing access port 260. InFIG. 2A, the flushing access port 260 is configured to receive a tip ofa syringe (not shown). In various embodiments of the present invention,the filter comprises a connector (not shown). The connector can be afemale Luer lock fitting that is capable of accepting a male Luer locktipped syringe. In various other embodiments of the present invention,while the flushing access port 260 can accept a syringe having a maleLuer lock tip, the access connector will not have a female Luer lockfitting. The center part of the syringe's male Luer lock fitting can beinserted through the flushing access port 260, and the fluid therein canbe introduced into the flush device 210.

In an embodiment of the present invention, the flushing access channel262 can further define an access valve (not shown). The additionalaccess valve can serve to prevent contamination of the system andspillage of the fluids contained therein.

In various embodiments of the present invention, when the valve plate220 is in the first position, it is received within the flushing accesschannel 262. Additionally, the valve plate 220 can abut the access valveseat 240. When the syringe is inserted and the flush fluid introduced,the pressure of the flush fluid can unseat the valve plate 220 from theaccess valve seat 240 and move the valve plate 220 to the secondposition. The seal created by the valve plate 220 and the access valveseat 240 can serve as the access valve. In addition, the seal created bythe valve plate 220 and the access valve seat 240 can serve inconjunction with the spring 290 to act as the access valve.Additionally, the seal created by the valve plate 220 and the accessvalve seat 240 can serve in conjunction with an additional valve to actas the access valve. This arrangement can provide further protectionfrom spillage and/or contamination.

In an embodiment of the present invention, the drainage port 270 canhave a drainage connector 272. In some embodiments, the connector is aconventional male Luer lock fitting (not shown). There can also be athreaded portion 274 that can accept a corresponding male threadedportion (not shown). Other conventional fittings can be used as well.Other embodiments of the drainage connector 272 can be a female Luerlock fitting with threaded portion (not shown) into which a male Luerlock fitting can be inserted (not shown).

In an embodiment of the present invention, the inlet port 280 can havean inlet connector 282. In various embodiments of the present invention,the connector is a conventional female Luer lock fitting 282 withthreaded portion 284 (see FIG. 2). A male Luer lock fitting (not shown)can be inserted and rotate about the female Luer lock fitting 282. Themale Luer lock fitting can have threaded portion (not shown) that canaccept the corresponding threaded portion 284 of the female Luer lockfitting 282. Other conventional fittings can be used as well. Otherembodiments of the inlet connector 282 include a male Luer lock fitting(not shown) and the threaded portion (not shown) that accepts acorresponding female threaded portion (not shown).

In an embodiment of the present invention, the in-line valve seat 240can be located where the channel 250 and the inlet portion meet. Theshape of the in-line valve seat 240 can be such that it can form a sealwith the valve plate 220 when it is in the second position. The profileof the in-line valve seat 240 can be vertical or diagonal. If theprofile of the in-line valve seat 240 is diagonal, this can limit therange of movement required by the valve plate 220 to actuate from thefirst position to the second position.

In an embodiment of the present invention, the inline valve seat canalso either be a projection or a ledge defined by the channel 250 andwall of the inlet conduit.

In various embodiments of the present invention, the valve plate 220 canhave a variety of outlines. The outline can be round, rounded with alinear side, square, and triangular. The cross-section of the valveplate 220 can have an angled lower end, vary in thickness, be linear, beconcave, and/or be convex. The concaved cross-section can help increasethe pressure applied against the in-line valve seat in the secondposition. Additionally, the angled lower end can help prevent the valveplate from catching on particulate and help force the valve plate 220into the first position as matter flows through the channel. The angledlower end can span the entire portion of the valve plate 220 and canextend along the entire exposed periphery of the valve plate (e.g. thepart that is not attached to the hinge), the leading edge of the valveplate that encounters the downstream flow, or any portion thereof. It isalso understood that valve plate 220 can have appropriate accommodationin the first position so that it will not impede flow.

In an embodiment of the present invention, a spring 290 biases the valveplate 220 toward the first position (see FIG. 4A and FIG. 4C). In anembodiment of the invention, the spring 290 is a tension spring. In analternative embodiment of the invention, the spring 290 is a compressionspring. In another embodiment of the invention, the spring 290 is a wiretorsion spring. In a further embodiment of the invention, the spring 290is a double wire torsion spring with an offset. In another embodiment ofthe invention, one of the hook ends of the wire torsion spring 290 canbe embedded in the body 285 of the flush device 210. In anotherembodiment of the invention, one of the hook ends of the wire torsionspring 290 can be embedded in the body of the valve plate 220.

In an embodiment of the present invention, the inlet port 280, channel250, flushing access channel 262, drainage port 270, or any combinationthereof is made of a translucent material that can allow a person to seethe valve plate 220 in at least the second position. The valve plate canhave a colour that makes it easier to see. In other embodiments thevalve plate 220 can have a coloured dot or other marking that can beseen through the translucent body by the flush device operator.

As mentioned above, in some embodiments, the valve plate 220 of theflushing access port 260 can form a seal in the first position with theaccess valve seat 240. In other embodiments that valve plate 220 canhave a projection that can correspond with the access orifice 264 (seeFIG. 3C); such that when the valve plate 220 is in the first position,the projection can reside in the access orifice. The access orifice 264can serve as the access valve seat 240 or as an additional valve seat.In one embodiment the projection is round and the flushing accesschannel defines a stepped cross-section that can accommodate the valveplate 220 and the projection when the valve plate 220 is in the firstposition.

In an embodiment of the invention, the flush device includes an externalleak detector. In an embodiment of the invention, detection of leakingserum activates one or more functions selected from the group consistingof activate an alarm; terminate a flushing operation; raise an alarm andinitiate a flushing operation sequence to reseal the flange and raise analarm and an auto shut-off sequence.

In an embodiment of the present invention, wireless communicationscircuitry can provide modulated waveform signals in either the infrared(IR) or radio frequency (RF) signal range. In an embodiment of theinvention, the wireless communications circuitry can provide RFinputs/outputs. The modulated signals can be transmitted using anytypical small computer Ethernet system WiFi standard such asEIA-802.11G, Bluetooth® methodology or discrete signalling utilizing anon-linear code encryption algorithm for secure control. The wirelesscommunications circuitry can be controlled through an interface with thedevice processor circuitry to provide remote control and data transferbetween the flush device 210 and peripheral devices such as: remotecontrol units (pushbuttons, foot switches), devices for monitoring thecontent of the drainage bag, devices for monitoring the leakage of fluidfrom the flush device 210, personal computers, printers or otherportable computing devices such as personal digital assistants (PDA),mass storage devices, or digital telecom devices such as cellulartelephones.

In an embodiment of the present invention, device processor circuitrycan be comprised of typical microprocessor electronic componentsnecessary to provide pre-programmed and user-selected operation of theflush device 210. In various embodiments of the present invention,components of the processor circuitry include but are not limited to:volatile and non-volatile memory, real-time clocking, and peripheralinterface and logic devices. In an embodiment of the present invention,a sensor can monitor the back pressure of the flush device 210 and alertthe attendant of the need to flush a stent, a catheter, tubing and/or afilter. In an alternative embodiment of the present invention, a sensorcan monitor the back pressure of the flush device 210 and carry out aperiodic flushing of a stent, a catheter, tubing and/or a filter. Basedon the back pressure during the periodic flushing the processor can beprogrammed to determine that (i) there is no impediment of the stent,the catheter, tubing and/or the filter and return the flush device 210to drainage until the next periodic check, (ii) there is an impedimentto the stent, catheter, tubing and/or filter and undertake an extendedflushing until the impediment is removed and then return the flushdevice 210 to drainage until the next periodic check, or (iii) there isan impediment that is not removed by flushing that requires interventionand then return the flush device 210 for limited drainage and alert forintervention. In an embodiment of the present invention, the flushdevice 210 alerts the physician and/or user when flushing fails tounclog the stent, catheter, tubing and/or filter. In an embodiment ofthe present invention, the system monitors the volume of liquid in thedrainage receptacle or bag and alerts personnel when the drainagereceptacle or bag requires maintenance. In an embodiment of the presentinvention, the system monitors for leaks in the flush device 210 andalerts personnel when there is a leak in the system. In an embodiment ofthe invention, monitoring for leaks can include chemical/biologicaldetection of the leaking fluid. In an embodiment of the invention,monitoring for leaks can be based on differentiating flushing fluid frombiological fluid using atmospheric ionization and spectroscopic analysisto analyse for chemical or biological markers present in the biologicalfluid but not present in the flushing fluid. In an embodiment of theinvention, monitoring for leaks with atmospheric ionization can utilizethe direct analysis real time (DART) technique as outlined in U.S. Pat.Nos. RE43,078, 7,700,913 and 7,777,181 entitled “ATMOSPHERIC PRESSUREION SOURCE”; “SAMPLING SYSTEM FOR USE WITH SURFACE IONIZATIONSPECTROSCOPY” and “HIGH RESOLUTION SAMPLING SYSTEM FOR USE WITH SURFACEIONIZATION TECHNOLOGY” which are herein expressly incorporated byreference in their entireties. In an embodiment of the presentinvention, an internal system processor firmware program can provide thedirection to operate the various circuit blocks that reside on thedevice circuit board. Functionality provided by the firmware caninclude:

a) comparison of desired and actual back pressure through the filter andflush device 210. In an embodiment of the present invention, a controlalgorithm can be used to control hysteresis and thereby minimize oreliminate oscillatory cycling of the back pressure alert;

b) activation of the back pressure valve to control the flushing deviceto flush the stent, catheter, tubing and/or filter and maintain theuser-selected back pressure;

c) logic output signal control to effect a proportional indication ofthe back pressure sensor signal at an LED bar graph indicator;

d) interface logic for the operator display and controls to provide useradjustments of the flush device 210 and to provide status messaging anddata during operation;

e) control of the wireless communication circuitry to implement theproperly formatted exchange of data with other peripheral devices; and

f) control of the external memory and interface port to provide theproper transfer of stored histogram data to external memory storagedevices, and the bi-directional communication required to effect remotecontrol of the flush device 210 using an external host computing device.

In an embodiment of the present invention, the flushing device can be aminiature pump utilizing any typical pressure building chamber-typemechanism such as diaphragm, bellows or piston. In an embodiment of thepresent invention, an energy storage device can provide power to adevice circuit board to control the flushing device.

In an embodiment of the present invention, the flushing device caninclude flexible tubing to deliver a filtered solution to the flushingdevice. The flexible tubing can be of surgical quality manufactured ofany typical material such as PVC, rubber (natural or synthetic),silicone or others. The flexible tubing can be sized to provide anairtight connection between the pump, the flush device 210.

In an embodiment of the present invention, a wireless control unit canbe a small form factor self-contained RF transmitter with an integralstorage battery power source. In an embodiment of the present invention,the wireless control unit can be wirelessly connected to the flushdevice 210 utilizing the wireless communications circuitry with discretesignalling utilizing a non-linear code encryption algorithm for securecontrol. The wireless control unit can allow the flush device 210 to beoperated remotely. Through the actuation of a single or predefinedcombination of buttons, the operation of the flush device 210 can becontrolled. Control functions include: pump on/off, switching of flow offlush device 210 from drainage to flush, flushing of the filter, flushtime duration, switching of flow from flush to drainage and adjustmentof other operating parameters as afforded by the device processorcircuitry.

The check valve can be an in-line, 2-port miniature fluid valveutilizing swing disk diaphragm, ball, or other seating methods typicalin the art. The check valve allows fluid flow in only one direction,away from the pump. Disk or ball check valves can be free moving orutilize levers or springs to assist in seating faster to eliminate fluidflow shock and/or inhibit fluid flow based upon applied pressure. Thecheck valve can be positioned to eliminate fluid leakage through thepump when the pump is not operating.

The flush device is initially in an ‘off’ state, with no power appliedto the internal components. Prior to operation, the physician attachesthe catheter 532 through an incision 515 in the epithelial tissue 518 tothe stomach 553 or liver 552 to be drained via the common bile duct 554of the duodenum 551 and connects the flush device to the catheter 532and a drainage bag (not shown) to the drainage port (not shown) of theflush device (see FIG. 5). A syringe or pump (not shown) with a salinesolution is connected to the flushing port of the flush device (notshown). Then the user applies positive pressure via the syringe or pumpto the flush device and positions the selector switch to the desiredoperating back pressure.

The device processor circuitry determines if the pump is required tooperate, or not, based upon the relationship between the user setting ofthe selector switch and the signal magnitude of the back pressure sensorand the time elapsed. Once activated the flush device begins to monitorand store the data including switching the flush device from drainage toflush and flushing to carry out a periodic check of the stent, catheter,tubing and/or filter back pressure and thereby monitor at regularintervals. If the back pressure sensor is lower than the desired readingthere is no impediment in the filter (i.e., the filter is not clogged orat risk of being clogged) as determined by the signal from the backpressure sensor and the flush device is switched from flush to drainage.However, if the back pressure sensor indicates a higher reading than thedesired level then the solution is passed through the stent, catheter,tubing and/or filter until either the back pressure reading falls belowa prescribed level or a duration of flushing time elapses. In thesituation when the time duration for flushing has elapsed and the backpressure has not fallen below the prescribed level an alarm may begin toindicate that the filter is blocked. The relative back pressure sensorreading is given by the LED bar graph indicator, with the value of theback pressure sensor signal proportionately indicated by sequential LEDindicator illumination from the bottom of the bar graph to the top.

During the operation of the flush device, back pressure data can bestored in non-volatile memory that forms a part of the device processorcircuitry. The back pressure data can be stored sequentially withassociated real-time (time of day) values that provide a directcorrelation of the operating back pressure at a given time. The storedmemory data can be retrieved by the user. In various embodiments of theinvention, the stored memory data can be retrieved by: (a) negotiationand data download to an external device using the wireless communicationcircuitry, (b) insertion of a non-volatile memory device (flash/thumbdrive) at the external memory and interface port; or (c) by request(serial communication) of a host computer connected to the externalmemory and interface port.

With the operator display and controls, the user may perform variousfunctions that affect the operation of the flush device; these functionsinclude, but are not limited to: (i) adjust dead-band (+/− error rangeof back pressure signal when compared to desired background backpressure) and delay time before/after allowable error is exceeded toactivate/de-activate flush pump settings or parameters;

(ii) adjust preset back pressure values associated with the user backpressure selector switch;

(iii) monitor back pressure in real-time with display provided inselectable engineering units including mm/Hg, bar, mbar, torr, mtorr,PSI and kPa;

(iv) retrieve and view stored time-stamped back pressure histogramvalues; and

(v) adjust other system parameters associated with the functionality ofthe LED bar graph indicator and communication protocols used by theexternal memory and interface port and the wireless communicationcircuitry.

In an embodiment of the present invention, the back pressure selectorswitch can be expanded in functionality to include: more selections(positions) and factory pre-set operational values. In an alternativeembodiment of the present invention, the back pressure selector switchcan be eliminated completely and replaced by a single pre-set oradjustable setting through the use of the operator display and controls.In another embodiment of the present invention, the back pressureselector switch can be set according to the procedure being undertaken.In an embodiment of the present invention, the minimum and maximumpressure which can be selected during the procedure can be based on theprocedure being undertaken. In an embodiment of the present invention,the minimum and maximum pressure which can be selected can be based onthe stored identity of a physician carrying out the procedure. Theidentity of the physician carrying out the procedure can be detectedthrough a RFID reader associated with the flush device and a tagassociated with the physician. In an embodiment of the presentinvention, the minimum and maximum pressure which can be selected duringthe procedure can be restricted based on the procedure being undertaken.

The functionality of the LED bar graph indicator can be expanded toallow user selected indications that provide: 0-100% indication of theback pressure sensor signal, scaled to provide 0-100% indication of theback pressure selector switch pre-set range, or other user selectedrange of indication.

In an embodiment of the present invention, the flush device can bereconfigured to utilize simple electronic circuit components eliminatingthe need for the device processor circuitry.

In various embodiment of the present invention, the unique operationalcharacteristics of the flush device can be utilized with pumps of anysize or type by modifying the pump control circuitry and the backpressure sensor expanding the size and types of back pressure assisteddevices that can be supported.

In an embodiment of the present invention, the back pressure records canbe stored in the processor memory during the execution of the medicalprocedure. In an embodiment of the present invention, upon theconclusion of the procedure, the back pressure records, stored in theprocessor memory during the execution of the procedure can be retrieved.In an embodiment of the invention, the back pressure records can be inthe form of a histogram. The retrieval of the stored data can beperformed by the simple insertion of a flash memory device into theexternal memory and interface port or by connection of this port to ahost computer for subsequent download. Once the medical procedure iscompleted, and/or the stored data is retrieved, the flush device canthen be powered off using the power switch.

In an embodiment of the invention, the system control functionality ofthe flush device can be used to provide fluid delivery, through thesimple exchange of pump hose connectivity, sensor selection andprocessor firmware control algorithm changes.

In another embodiment of the invention, a Radio Frequency IDentification(RFID) tag is imbedded in one or more of: the flush devices. In anembodiment of the invention, the REID tag is used to identify the flushdevice and thereby determine the parameters for operation of the flushdevice. In one embodiment of the invention, the RFID tag operates usingan Ultra High Frequency (UHF) signal. In another embodiment of theinvention, the RFID tag operates using a microwave frequency signal.

In an embodiment of the present invention, a RFID reader is present inthe flush device which can then read the RFID tags in the individualfilter. In an embodiment of the invention, the RFID reader can bepositioned so that the RFID tag antenna is least affected by anyconducting material. In an embodiment of the present invention, amicrocontroller interfaces with an embedded RFID read/write module towrite to a programmable RFID tag.

In one embodiment the RFID tag is read only. In another embodiment, theRFID tag contains an Electrically Erasable Programmable Read-Only Memory(EPROM), which enables both read and write functions. In an embodimentof the invention, the RFID tag is passive. In another embodiment of theinvention, the RFID tag is semi-passive containing a source of energysuch as a battery to allow the tag to be constantly powered. In afurther embodiment of the invention, the RFID tag is active, containingan internal power source, such as a battery, which is used to power anyIntegrated Circuits (ICs) in the tag and generate the outgoing signal.In another embodiment, the tag has the ability to enable locationsensing through a photo sensor.

In an embodiment of the invention, the flush device is able to monitorthe type, previous use data and condition of the filter. In this manner,a physician can choose when a procedure warrants using the same flushdevice that has previously been used for a similar procedure usingsimilar parameters and under the same or similar conditions.

In one embodiment of the invention, means of communication with a basestation is embedded and/or associated with the flush device.

In one embodiment of the invention, the communication means utilizes oneor more of a wireless local area network; a wireless wide area network;a cellular network; a satellite network; a Wi-Fi network; and a pagernetwork. In one embodiment of the invention, a modem capable ofcommunicating with one or more of the aforementioned networks isembedded in the flush device. In the following discussion the term‘cellular modem’ will be used to describe the device embedded. The term‘cellular modem’ will be herein used to identify any device ofcomparable size capable of communicating over one or more of theaforementioned networks. In one embodiment of the invention, thecellular modem can be a Code Division Multiple Access (CDMA) modem. Inan embodiment of the invention, a RFID reader and associate integratedcircuit processor can be embedded together with the cellular modem inthe flush device. In such an embodiment, the RFID tags and RFID readercan be positioned to optimize the RFID read of the RFID tags from theavailable devices including the filter.

In an embodiment of the invention, a RFID reader and a cellular modemcan be positioned in the flush device; the RFID reader is incommunication with one or more RFID readers, associated cellular modemsand the RFID tags of one or more flush devices including the drainagebag and the filter. Through communications with the RFD reader andassociated integrated circuit processor of the plurality of flushdevices, a RFID reader and associated integrated circuit processor isable to distinguish the RFID tag from the drainage bag and the filter inthe vicinity based on one or more of location, strength of signal,variation of RFID tag signal with position, variation of RFID tag signalwith time and prior input data. In an embodiment of the invention, oneor more antenna can be used to help discriminate the location of theflush devices including the drainage bag and the filter. In anembodiment of the invention, the RFID reader and associate processor canbe in communication with the cellular modem. In an embodiment of theinvention, the cellular modem is in communication with a base stationand can transmit one or more parameters selected from the groupconsisting of one or more RFID tag location, one or more RFID tagidentification code, flush devices including the drainage bag and thefilter, flush device conditions, suction device conditions and timestamp.

In one embodiment of the invention the RFID code uses the IEEE formatand is Electronic Product Code (EPC) readable. In another embodiment ofthe invention the RFID code uses the UCC format and is Universal ProductCode (UPC) readable. In another embodiment, the format is compatible forEPC, European Article Number (EAN) and UPC read and write functions.

In an embodiment of the invention, the device method or system can beused for the treatment of humans. In an embodiment of the invention, thedevice method or system can be used for the treatment of animals. In anembodiment of the invention, the device method or system can be used inveterinary applications. In an embodiment of the invention, the devicemethod or system can be used in medical applications.

In an embodiment of the invention, a flush device including the drainagebag and the filter can be assembled as an integral unit. Thesecomponents can be attached within or onto integral to the flush devicehousing. The energy storage device and the pump can also be housed inthe integral flush device housing. In an embodiment of the invention, anintegral flush device is portable, ergonomic, and superior for in situuse. As the patient moves, the device can move to compensate for themovement. In contrast, if the flush device was separate, or relied upona tether to hold the device to the patient, then movement could jar anddetach the suction device.

In an embodiment of the invention, the flush device further comprisesone or both visual and audio feedback that allows one or more methods ofcontrol of the back pressure applied to the suction device, control ofthe flush device and adjustment of the flush device settings during theprocedure.

In an embodiment of the invention, the flush device is portable. In anembodiment of the invention, the flush device is hand held. In anembodiment of the invention, the flush device is portable and hand held.

In an embodiment of the invention, a method of adjusting and monitoringa flush device during a procedure, comprises receiving the catheter fromthe organ and the drainage bag and the filter, applying a back pressureto the filter during the procedure, wherein the flush device one or bothreceives and has preset parameters to control the back pressure to beapplied to the filter. Activating the flush device, wherein the flushdevice functions include monitoring the back pressure applied to thefilter via a sensor, comparing the back pressure applied to the filterand the parameters at regular time intervals using a processor andautomatically increasing the flushing of the filter when the comparisonindicates an increased back pressure. The method further comprisesmonitoring the flush device during the procedure using one or both audioor visual feedback from the flush device and adjusting the parametersselected in response to changed conditions of the procedure. In anembodiment of the invention, the back pressure is adjusted to controlagainst build up of material at the filter.

In an embodiment of the invention, the flush device can be applied inany scientific, manufacturing, or industrial apparatus that requiresfiltered fluid flow and the use of a flush cycle to clear the filterfollowed by a regulated constant or variable back pressure check todetermine that flow through the filter is not impeded. This can includelaboratory equipment that requires filtered fluid flow or any otherclinical procedure. The manipulation of components, fluids or assembliesused in a manufacturing process, including: precision handling,clean-room transport, and material transport can also be supported.

Various embodiments can be implemented using a conventional generalpurpose or specialized digital computer(s) and/or processor(s)programmed according to the teachings of the present disclosure, as willbe apparent to those skilled in the computer art. Appropriate softwarecoding can readily be prepared by skilled programmers based on theteachings of the present disclosure, as will be apparent to thoseskilled in the software art. The invention can also be implemented bythe preparation of integrated circuits and/or by interconnecting anappropriate network of component circuits, as will be readily apparentto those skilled in the art.

Embodiments of the present invention can include a computer readablemedium, such as computer readable storage medium. The computer readablestorage medium can have stored instructions which can be used to programa computer to perform any of the features present herein. The storagemedium can include, but is not limited to, any type of disk includingfloppy disks, optical discs, DVD, CD-ROMs, micro drive, andmagneto-optical disks, ROMs, RAMs, EPROMs, EEPROMs, DRAMs, flash memoryor any media or device suitable for storing instructions and/or data.The present invention can include software for controlling both thehardware of a computer, such as general purpose/specialized computer(s)or microprocessor(s), and for enabling them to interact with a humanuser or other mechanism utilizing the results of the present invention.Such software may include, but is not limited to, device drivers,operating systems, execution environments/containers, and userapplications.

Embodiments of the present invention can include providing code forimplementing processes of the present invention. The providing caninclude providing code to a user in any manner. For example, theproviding can include transmitting digital signals containing the codeto a user; providing the code on a physical media to a user; or anyother method of making the code available.

Embodiments of the present invention can include a computer-implementedmethod for transmitting the code which can be executed at a computer toperform any of the processes of embodiments of the present invention.The transmitting can include transfer through any portion of a network,such as the Internet; through wires, the atmosphere or space; or anyother type of transmission. The transmitting can include initiating atransmission of code; or causing the code to pass into any region orcountry from another region or country. A transmission to a user caninclude any transmission received by the user in any region or country,regardless of the location from which the transmission is sent.

In an embodiment of the invention, a flush device comprises a drainageport connectable via a filter to a source of unfiltered fluid, an inletport in connection with one or both a waste line and a containment bagand a flushing port which can be connected to a fluid reservoir. Theflush further comprises a back pressure sensor and a moveable flange fordirecting the flow from the drainage port to one of the inlet port andthe flushing port.

A method of operating a flush device comprises the steps of receivingthe flush, connecting a drainage port of the flush with a source ofunfiltered serum and connecting an inlet port of the flush with one orboth a waste line and a waste container. The method further comprisesthe steps of connecting a flushing port of the flush to a fluidreservoir containing a fluid and monitoring a back pressure sensor todetect one or both a background back pressure and an increase in theback pressure above the background back pressure. The method furthercomprises the steps of activating a flange to direct a connectionbetween the drainage port and the inlet port to a connection between thedrainage port and the flushing port when the back pressure sensordetects a back pressure greater than the background back pressure andsupplying the fluid from the fluid reservoir to the flush. The method ofoperating the flush where the fluid from the fluid reservoir is suppliedto the flush for a specified period of time.

The foregoing description of embodiments of the methods, systems, andcomponents of the present invention has been provided for the purposesof illustration and description. It is not intended to be exhaustive orto limit the invention to the precise forms disclosed. Manymodifications and variations will be apparent to one of ordinary skillin the relevant arts. For example, steps performed in the embodiments ofthe invention disclosed can be performed in alternate orders, certainsteps can be omitted, and additional steps can be added. The embodimentswere chosen and described in order to best explain the principles of theinvention and its practical application, thereby enabling others skilledin the art to understand the invention for various embodiments and withvarious modifications that are suited to the particular usedcontemplated. Other embodiments are possible and are covered by theinvention. Such embodiments will be apparent to persons skilled in therelevant art(s) based on the teachings contained herein. The breadth andscope of the present invention should not be limited by any of theabove-described exemplary embodiments, but should be defined only inaccordance with the following claims and their equivalents.

While the present invention has been described in some detail forpurposes of clarity and understanding, one skilled in the art willappreciate that various changes in form and detail can be made withoutdeparting from the true scope of the invention. All figures, tables, andappendices, as well as patents, applications, and publications, referredto above, are hereby incorporated by reference.

What is claimed is:
 1. A flushing device comprising: (a) an inlet portadapted to be connected with a source of bodily fluid; (b) a drainageport adapted to be connected to a drainage container; (c) a flushingport adapted to be connected to a fluid reservoir containing a flushingfluid; (d) a pump adapted to pump the flushing fluid into the flushingport; (e) a valve including a flange, where in a first configuration adrainage flow path is defined from the inlet port through the flushingdevice and through the drainage port, and the inlet port is isolatedfrom the flushing port, and where in a second configuration a flushingflow path is defined from the flushing port through the flushing deviceand through the inlet port, and the inlet port is isolated from thedrainage port, and where activating the valve moves the flange to changethe valve from the first configuration to the second configuration; (f)wherein the flange is configured to rotate about a hinge disposed on aside of the flushing port closer to the drainage port than to the inletport; (g) wherein the flange is biased into the first configuration; and(h) wherein when the valve is in the first configuration the drainageflow path is direct and uninterrupted so that a passive flow of bodilyfluids can flow passively along the drainage flow path from the inletport through the flushing device and out of the drainage port.
 2. Theflushing device of claim 1, wherein an inlet lumen is adjacent the inletport, a drainage lumen is adjacent the drainage port, and a transitionspace is disposed between the inlet lumen and drainage lumen, and aleading edge of the flange is disposed in the transition space and isspaced from the inlet lumen and drainage lumen in a direction transverseto the drainage flow path when the valve is in the first configuration.3. The flushing device of claim 2, configured so that activating thepump pressurizes the flushing fluid sufficiently to activate the valveand direct flushing fluid along the flushing flow path sufficient toovercome the passive flow of bodily fluids.
 4. The flushing device ofclaim 2, additionally comprising a drainage opening between thetransition space and the drainage lumen, wherein a valve seat surface ofthe transition space extends around the circumference of the drainageopening and extends in a direction transverse to the drainage flow path,and wherein when the valve is in the second configuration the flangeengages the valve seat surface so as to seal the drainage lumen relativeto the transition space.
 5. The flushing device of claim 4, wherein theflushing port is configured so that the pump can be releasably attachedthereto, and when the pump is attached to the flushing port the flangeis moved to change the valve from the first configuration to the secondconfiguration.
 6. A flushing device for draining bodily fluid,comprising: a first port configured to be attachable to a catheteradapted to receive bodily fluid draining from a patient; a second portconfigured to be communicably attached to a container adapted to receivebodily fluid drained from the patient; a drainage channel formed withinthe flushing device between the first port and the second port, thedrainage channel configured so that a passive bodily fluid flow flowingfrom the patient entering the first port flows without interruptionthrough the flushing device along a drainage fluid flow path of thedrainage channel to and through the second port; a flushing fluid inputport between the first and second ports, the flushing fluid input portconfigured to selectively receive a source of flushing fluid, a flushingaccess channel extending from the flushing fluid input port andintersecting the drainage channel; a valve seat interposed between theflushing fluid input port and the drainage channel; and a plateconfigured to rotate about a hinge between a first position in which theplate is received by the valve seat so as to block the flushing accesschannel and a second position in which the plate blocks the drainagefluid flow path between the first and second ports, the plate beingbiased to the first position, the hinge disposed on a side of theflushing fluid input port closer to the second port than to the firstport; wherein the flushing device is configured so that when flushingfluid is delivered from the source of flushing fluid at a pressuresufficient to overcome the bias, the plate is rotated from the firstposition to the second position so that the drainage fluid flow path isblocked between the flushing fluid input port and the second port, and aflushing flow path is established between the flushing fluid input portand the first port, and the flushing fluid is infused at sufficientpressure to overcome the passive bodily fluid flow so that that flushingfluid flows along the flushing flow path; and wherein the flushingdevice is configured so that when flushing fluid ceases to be deliveredfrom the source of flushing fluid, the plate automatically moves backinto the first position and no longer blocks the flow path between thefirst and second ports so that passive bodily fluid flow again can flowthrough the flushing device along the drainage fluid flow path.
 7. Theflushing device of claim 6, wherein the flushing access channelintersects the drainage channel at an intersecting section, the drainagefluid flow path extending through the intersecting section, and whereinwhen the plate is moved toward the second position, the plate moves intothe drainage fluid flow path in the intersecting section.
 8. Theflushing device of claim 7, configured so that attaching the source offlushing fluid to the flushing fluid input port does not move the platefrom the first position.
 9. The flushing device of claim 8, wherein theflushing fluid input port is spaced from the drainage channel, and aleading edge of the plate is spaced from the drainage fluid flow pathwhen the plate is in the first position.
 10. The flushing device ofclaim 7, comprising an elongated first lumen adjacent the first port andan elongated second lumen adjacent the second port, wherein theintersecting section is disposed between the first and second lumens, adiameter of the intersecting section being greater than diameters of thefirst and second lumens, and a second valve seat is defined by a surfacein the intersecting section adjacent the second lumen, the surfaceextending transverse to the drainage fluid flow path, and wherein whenthe plate is in the second position the plate engages the second valveseat surface so as to seal the second valve seat.
 11. The flushingdevice of claim 10, wherein when the plate is in the first position itis disposed within the intersecting section and spaced a transversedistance from the first and second lumens.
 12. The flushing device ofclaim 11, wherein the plate is configured so that when it is in thesecond position a center axis of the plate is spaced from an axis of thedrainage fluid flow path.
 13. The flushing device of claim 7, configuredso that when the source of flushing fluid is attached to the flushingfluid input port the plate is displaced from the first position towardthe second position.
 14. The flushing device of 6, wherein the secondport comprises a second valve seat having a sealing surface transverseto the drainage fluid flow path, and wherein when the plate is in thesecond position, the plate is engaged with the second valve seat so asto close the second port.
 15. The flushing device of claim 6, whereinthe plate is biased into the first position by a spring.
 16. A flushingdevice for draining bodily fluid, comprising: a first port configured tobe attachable to a catheter adapted to receive bodily fluid drainingfrom a patient; a second port configured to be communicably attached toa container adapted to receive bodily fluid drained from the patient; adrainage channel formed within the flushing device between the firstport and the second port, the drainage channel configured so that apassive bodily fluid flow flowing from the patient entering the firstport flows through the flushing device along a drainage fluid flow pathof the drainage channel to and through the second port; a flushing fluidinput port between the first and second ports, the flushing fluid inputport configured to selectively receive a source of flushing fluid, aflushing access channel extending from the flushing fluid input port andintersecting the drainage channel; a valve seat interposed between theflushing fluid input port and the drainage channel; and a plateconfigured to move between a first position and a second position,wherein when the plate is in the first position the plate is received bythe valve seat so as to be disposed within the flushing access channeland spaced from the drainage channel, wherein when the plate is in thesecond position the plate extends into the drainage channel between thefirst and second ports, and wherein the plate is biased toward the firstposition; wherein the flushing device is configured so that whenflushing fluid is delivered from the source of flushing fluid at apressure sufficient to overcome the bias of the plate toward the firstposition, the plate is moved from the first position to the secondposition so that the drainage fluid flow path is blocked between theflushing fluid input port and the second port, and a flushing flow pathis established between the flushing fluid input port and the first port,and the flushing fluid is infused at sufficient pressure to overcome thepassive bodily fluid flow so that that flushing fluid flows along theflushing flow path; and wherein the flushing device is configured sothat when flushing fluid ceases to be delivered from the source offlushing fluid, the plate automatically moves back into the firstposition and no longer blocks the drainage fluid flow path between thefirst and second ports so that passive bodily fluid flow again can flowthrough the flushing device along the drainage fluid flow path.
 17. Theflushing device of claim 16, wherein a leading edge of the plate isspaced from the drainage fluid flow path when in the first position. 18.The flushing device of claim 17, wherein when the plate is moved towardthe second position, the leading edge of the plate moves into thedrainage fluid flow path.